Crixivan

"If you think you are at risk of getting HIV, ask your health care provider if PrEP is right for you. Along with other prevention methods like condoms, PrEP can offer good protection against HIV if taken every day.

For Patients

Crixivan (indinavir sulfate) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is a type of antiviral medication called a protease inhibitor. Common side effects include stomach pain, nausea, vomiting, heartburn, loss of appetite, or headache.

The recommended dosage of Crixivan is 800 mg (usually two 400-mg capsules) orally every 8 hours. Crixivan may interact with injectable midazolam, fluticasone, St. John's wort, antibiotics, antidepressants, calcium channel blockers, cholesterol-lowering medicines, drugs that weaken the immune system, heart rhythm medications, insulin or oral diabetes medications, medicines to treat erectile dysfunction, other HIV /AIDS medicines, or seizure medications. Many other medicines can interact with Crixivan. Tell your doctor all medications you use. During pregnancy, Crixivan should be used only when prescribed. It is normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Our Crixivan (indinavir sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Stomach pain, nausea, vomiting, heartburn, loss of appetite, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Indinavir may cause kidney stones. Tell your doctor immediately if you have symptoms such as side or mid-back pain, pink/bloody urine, or pain with urination.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, check your blood sugar levels regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Clinical Trials In Adults

Nephrolithiasis/urolithiasis, including flank pain with
or without hematuria (including microscopic hematuria), has been reported in
approximately 12.4% (301/2429; range across individual trials: 4.7% to 34.4%)
of patients receiving CRIXIVAN at the recommended dose in clinical trials with
a median follow-up of 47 weeks (range: 1 day to 242 weeks; 2238 patient-years
follow-up). The cumulative frequency of nephrolithiasis events increases with
duration of exposure to CRIXIVAN; however, the risk over time remains
relatively constant. Of the patients treated with CRIXIVAN who developed
nephrolithiasis/urolithiasis in clinical trials during the double-blind phase,
2.8% (7/246) were reported to develop hydronephrosis and 4.5% (11/246)
underwent stent placement. Following the acute episode, 4.9% (12/246) of
patients discontinued therapy. (SeeWARNINGS and DOSAGE AND
ADMINISTRATION, Nephrolithiasis/Urolithiasis.)

Asymptomatic hyperbilirubinemia (total bilirubin
≥ 2.5 mg/dL), reported predominantly as elevated indirect bilirubin, has
occurred in approximately 14% of patients treated with CRIXIVAN. In < 1% this
was associated with elevations in ALT or AST.

Study ACTG 320 of Unknown Drug Relationship and of Severe or Life-threatening Intensity

CRIXIVAN Percent
(n=332)

CRIXIVAN plus Zidovudine Percent
(n=332)

Zidovudine Percent
(n=332)

CRIXIVAN plus Zidovudine plus Lamivudine Percent
(n=571)

Zidovudine plus Lamivudine Percent
(n=575)

Body as a Whole

Abdominal pain

16.6

16.0

12.0

1.9

0.7

Asthenia/ fatigue

2.1

4.2

3.6

2.4

4.5

Fever

1.5

1.5

2.1

3.8

3.0

Malaise

2.1

2.7

1.8

0

0

Digestive System

Nausea

11.7

31.9

19.6

2.8

1.4

Diarrhea

3.3

3.0

2.4

0.9

1.2

Vomiting

8.4

17.8

9.0

1.4

1.4

Acid regurgitation

2.7

5.4

1.8

0.4

0

Anorexia

2.7

5.4

3.0

0.5

0.2

Appetite increase

2.1

1.5

1.2

0

0

Dyspepsia

1.5

2.7

0.9

0

0

Jaundice

1.5

2.1

0.3

0

0

Hemic and Lymphatic System

Anemia

0.6

1.2

2.1

2.4

3.5

Musculoskeletal System

Back pain

8.4

4.5

1.5

0.9

0.7

Nervous System/ Psychiatric

Headache

5.4

9.6

6.0

2.4

2.8

Dizziness

3.0

3.9

0.9

0.5

0.7

Somnolence

2.4

3.3

3.3

0

0

Skin and Skin Appendage

Pruritus

4.2

2.4

1.8

0.5

0

Rash

1.2

0.6

2.4

1.1

0.5

Respiratory System

Cough

1.5

0.3

0.6

1.6

1.0

Difficulty breathing/ dyspnea/ shortness of breath

0

0.6

0.3

1.8

1.0

Urogenital System

Nephrolithiasis/ urolithiasis

8.7

7.8

2.1

2.6

0.3

Dysuria

1.5

2.4

0.3

0.4

0.2

Special Senses

Taste perversion

2.7

8.4

1.2

0.2

0

*Including renal colic, and
flank pain with and without hematuria

In Phase I and II controlled
trials, the following adverse events were reported significantly more
frequently by those randomized to the arms containing CRIXIVAN than by those
randomized to nucleoside analogues: rash, upper respiratory infection, dry
skin, pharyngitis, taste perversion.